ELECSYS CEA ASSAY
Received Mar 17, 2023 · Event occurred Feb 21, 2023
Report 1823260-2023-00862 · MDR key 16567020
Device
Generic name
System, Test, Carcinoembryonic Antigen
Manufacturer
Roche DiagnosticsModel number
NACatalog number
ASKU
Lot number
ASKU
Product problems
- Mechanical Problem
- High Test Results
- Mechanical Problem
- High Test Results
Patient
74 YR · Female
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THERE WAS AN ALLEGATION OF QUESTIONABLE HIGH RESULTS FOR MULTIPLE ASSAYS FOR ONE PATIENT FROM COBAS E 801 ANALYTICAL UNIT SERIAL NUMBER (B)(4). THE RESULTS WERE REPORTED OUTSIDE OF THE LABORATORY AND THE DOCTOR BELIEVED THE RESULTS DID NOT MATCH THE MEDICAL IMAGING RESULTS AND QUESTIONED IF THERE WERE INTERFERING SUBSTANCES. REFER TO THE ATTACHMENT TO THE MEDWATCH FOR ALL PATIENT DATA. REFER TO THE MEDWATCHES WITH THE FOLLOWING A1 PATIENT IDENTIFIERS FOR ALL INVOLVED ASSAYS: (B)(6) FOR THE CA 15-3 ASSAY. (B)(6) FOR THE CEA ASSAY. (B)(6) FOR THE CYFRA 21-1 ASSAY. (B)(6) FOR THE CA19-9 ASSAY. (B)(6) FOR THE CA 125 ASSAY. (B)(6) FOR THE AFP ASSAY.
Additional Manufacturer Narrative
A SAMPLE FROM THE PATIENT WAS SUBMITTED FOR INVESTIGATION.
Additional Manufacturer Narrative
THE PATIENT SAMPLE WAS INVESTIGATED AND NO CAUSE FOR THE RESULT DISCREPANCIES COULD BE FOUND. THE CUSTOMER¿S RESULTS WERE CONFIRMED. NO PRODUCT ISSUE WAS FOUND AND THE REAGENT PERFORMED WITHIN SPECIFICATIONS. A GENERAL REAGENT-RELATED ISSUE COULD BE EXCLUDED.